A senior Food and Drug Administration official has said that the manufacturers' tests of procedures to clean medical scopes linked with "superbug" outbreaks contained flaws which make their cleaning instructions unreliable.
The scopes were linked to the exposure of 179 patients to drug-resistant bacteria at UCLA's Ronald Reagan Medical Center in Los Angeles and may have contributed to two deaths. Those incidents came to light in February.
A superbug outbreak was registered at a hospital in Illinois in February and at that time the FDA asked Fujifilm Holdings Corp, Olympus Corp and Pentax, which make the devices, to submit their test results for review, Dr. Stephen Ostroff, the chief scientist of the FDA said.
He added the tests were not carried out properly in some cases while in some cases they were properly conducted but the cleaning and disinfecting protocol failed. Ostroff is in line to become the FDA's acting commissioner when Dr. Margaret Hamburg leaves at the end of March.
It is learned that the deficiencies in the tests conducted by the companies were not reported.
The flawed data raise question over the reliability of all current cleaning and disinfecting protocols.
According to FDA, even when hospitals follow the instructions laid down by the manufacturers for cleaning scopes, the patients have contracted multidrug-resistant bacterial infections.
As per the guidance issued in 1996, the companies making duodenoscopes are not asked to submit data and they are just asked to attest that cleaning protocols used in their own studies were effective. The companies set their own standards for effectiveness.
But the Illinois outbreak has forced the FDA to pass a ruling saying that it would require duodenoscope manufacturers to provide underlying test data at the time they apply for marketing approval.